SOV
Form # 10700
R: 06.06
Phone: 1-888-445-0497
State of Maine Department of Health & Human Services
MaineCare/MEDEL Prior Authorization Form
Sovaldi® Request
www.mainecarepdl.org
Member ID #: |__|__|__|__|__|__|__|__|__|
Fax: 1-888-879-6938
Patient Name: ____________________________________ DOB: __________________
(NOT MEDICARE NUMBER)
Patient Address:_________________________________________________________________________________________________
Provider DEA: |__|__|__|__|__|__|__|__|__|
Provider NPI: __|__|__|__|__|__|__|__|__|__|
Provider Name:_______________________________________________________________________ Phone:____________________
Provider Address:_____________________________________________________________________
Fax:____________________
Pharmacy Name:_____________________________Rx Address:________________________________Rx phone:_________________
Provider must fill all information above. It must be legible, correct and complete or form will be returned.
(Pharmacy use only):
NPI: __|__|__|__|__|__|__|__|__|__| NABP: |__|__|__|__|__|__|__| NDC: |__|__|__|__|__|__|__|__|__|__|__|
MaineCare will approve Sovaldi® PA requests for members who meet the following guidelines. This PA form will cover the
first two 14 day fills and a subsequent 28 day fill. The first and second pages list the various regimens and the clinical
situations for which they will be considered medically necessary according to MaineCare criteria, as well as the required
supporting documentation. The PA must be approved prior to the 1 st dose. Please review Sovaldi® criteria on
MaineCarepdl.org for additional reporting needed for continuation of therapy prior to the 3 rd month of therapy starts.

Genotype 1
 Treatment naïve/relapsed (regardless of HIV co-infection) Regimen 1
 Prior null or partial response (w/ or w/out a protease inhibitor)  Regimen 2
 IFN intolerant* AND Child-Pugh < 6  Regimen 5
 IFN-Intolerant* AND Child-Pugh >6  Regimen 6
 HIV+, prior null or partial response to PEG/RBV PLUS a protease inhibitor  Regimen 2
 HIV+, AND prior PEG/RBV non-response  Regimen 5
 Re-infection of allograft liver after transplant Regimen 6

Genotype 2
 Treatment naïve or relapsed, or null responders w/OUT cirrhosis  Regimen 3
 Treatment experienced w/ prior null or partial response WITH cirrhosis  Regimen 1
 Treatment naïve or relapsed, or null responders WITH cirrhosis, AND
o IFN-Intolerant*  Regimen 4
 Re-infection of allograft liver after transplant  Regimen 6

Genotype 3
 Regardless of prior treatment  Regimen 1
 IFN-Intolerant*  Regimen 6
 Re-infection of allograft liver after transplant  Regimen 6

Genotype 4
 Regardless of prior treatment  Regimen 1
 IFN-Intolerant*  Regimen 6

Genotype 5 or 6
 Regardless of prior treatment  Regimen 1

Awaiting Liver Transplant
 Patient has diagnosis of hepatocellular carcinoma and is awaiting transplant  Regimen 7
SOV
Form # 10700
R: 06.06
REGIMENS:
1. Sovaldi 400mg daily w/ weight-based RBV plus weekly PEG/IFN x84 days (12 weeks) 
2. Sovaldi 400mg daily w/ weight-based RBV plus weekly PEG/IFN x84 days (12 weeks), AND
 An additional 84 days (12 weeks) of PEG/IFN to follow 
3. Sovaldi 400mg daily w/ weight-based RBV x84 days (12 weeks) 
4. Sovaldi 400mg daily w/ weight-based RBV x112 days (16 weeks) 
5. Sovaldi 400mg daily PLUS Olysio 150mg daily w/ or w/out weight-based RBV x84 days (12 weeks) 
6. Sovaldi 400mg daily w/ weight-based RBV x168 days (24 weeks) 
 If being for re-infection of allograft liver: will require documented recommendations from transplant center and use of weekly PEG/IFN if tolerated
7. Sovaldi 400mg daily w/ weight-based RBV (for up to 48 weeks or until liver transplant) 
 Will require documentation of diagnosis and reauthorization every 28 days
 OTHER:
Please provide clinical rationale for choosing a regimen that is beyond those found within the current guidelines, or for selecting any of the
above regimens for alternate genotypes/patient populations.
Sovaldi 400mg daily w/
____________________________________________x
days (
weeks)
The following documentation must be submitted with initial request for consideration of approval:
 Active HCV infection verified by viral load within the last year
 Prescriber is, or has consulted with, a gastroenterologist,



hepatologist, ID specialist or other Hepatitis specialist.
Requires consult within the past year with documentation of
recommended regimen
Patient is not receiving dialysis and has CrCl > 30mL/min
 Verified by lab results including a creatinine level
within the past 6 months
 HCV Genotype verified by lab
 Documentation of counseling regarding
abstinence from alcohol, IV drug use and
education on how to prevent HCV transmission
 Current medication list that does NOT include:
carbamazepine, phenytoin, Phenobarbital,
oxcarbazepine, rifabutin, rifampin, rifapentine, St.
John’s Wort or tipranavir.
For women of childbearing potential (and male patients with female partners of childbearing potential):
 Patient is not pregnant (or a male with a pregnant female partner) and not planning to become pregnant during
treatment or within 6 months of stopping
 Agreement that partners will use two forms of effective non-hormonal contraception during treatment and for at
least 6 months after stopping
 Verification that monthly pregnancy tests will be performed throughout treatment
For IFN-Intolerant* (for use with regimens 4, 5, 6 or Other if applicable):





Documented life-threatening side effects or potential side effects (i.e. history of suicidality)
Decompensated cirrhosis (Child-Pugh >6)
 Or Child-Pugh > 6 if co-infected with HIV
Blood dyscrasias:
 Baseline neutrophil count <1500/µL, baseline platelets <90,000/µL or baseline Hgb <10g/dL
Pre-existing unstable or significant cardiac disease (e.g. history of MI or acute coronary syndrome)
Other: _____________________________________________
Pursuant to the MaineCare Benefits Manual, Chapter I, Section 1.16, The Department regards adequate clinical records as essential for the delivery of quality care, such comprehensive records
are key documents for post payment review. Your authorization certifies that the above request is medically necessary, meets the MaineCare criteria for prior authorization, does not exceed the
medical needs of the member and is supported in your medical records.
Provider Signature: _______________________________ Date of Submission: ______________________________
*MUST MATCH PROVIDER LISTED ABOVE